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Tuan T. Phan


Electronic spreadsheets are a valuable and pervasive industry tool but have yet to catch up with regulatory compliance demands without the implementation of an auxiliary program.

From a historical perspective, the author discusses factors and strategies in this article for developing a spreadsheet validation plan.


Requirements traceability matrix
Requirements traceability matrix

The test cases must also be developed so they will exercise the system to challenge its operations and performance against the predetermined criteria, especially for its most critical parameters.

The test cases must be executed and the results must be recorded and evaluated to determine whether the results show that the software or application has been validated for its intended use.

It may also be helpful to tie the test cases to the user requirements and to the design elements through a requirements traceability matrix.


2003, Pharmaceutical Technology, January, pages 50-62

Full article

Validation of electronic spreadsheets for complying with 21 CFR Part 11